Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611566
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
VR-guided Exercise and Mindfulness Program for People with Chronic Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Virtual-reality-guided Exercise and Mindfulness Program for People with Chronic Pain Under Rehabilitation a Randomised Controlled Cross-over Trial
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VRalgia
Brief Summary:
In this study we assessed the feasibility of a VR-guided intervention seeking to improve physical fitness in individuals with chronic pain In a randomised controlled trial with a cross-over design and participants in rehabilitation for chronic pain were asked to perform in a counter-balanced order five minutes of aerobic exercise following identical instructions given through either a VR headset or TV screen The procedures were then repeated with mindfulness exercises Heart rate HR was monitored throughout all four sessions and participants self-reported perceived exercise intensity benefit relaxation and reward Paired Students t-test Wilcoxon signed rank test and McNemars test were performed to compare the outcome variables across sessions for individuals as appropriate
Detailed Description:
Participants were recruited through partner patients organizations a local exercise group aimed at people living with rheumatological conditions and an inpatient occupations rehabilitation centre
The study was conducted according to the Helsinki declaration and approved by the Local committee for medical and health research ethics at the Inland Norway University of Applied Sciences Ref 20616405
Study design The study was designed as a randomised controlled trial with a cross-over design
Intervntion Each participant underwent five exercise sessions in total Firstly all participants performed a six- minutes warm-up session following instructions projected on a TV screen Subsequently the participants performed two aerobic exercise sessions identical in content and duration five- minutes once following the instructions from VR VR-A and once following the identical program that was displayed on a TV screen TV-A The allocation of the first aerobic exercise session as VR-A or TV-A was randomly assigned for each individual After completing the first aerobic exercise session the participants were subsequently asked to complete the second session guided through the opposite mode of delivery After the exercise sessions the same randomised cross-over design was followed for two five- minute mindfulness sessions with the participants undergoing in a counter-balanced and random order a guided mindfulness program once delivered through VR VR-M and once displayed on a TV screen TV-M
Virtual environment and technology In the VR-A and VR-M the participants wore a stand-alone HMD Oculus Quest 2 with stock headstrap Meta Platforms Menlo Park California USA The virtual environment was developed by Fynd Reality AS Hamar Norway in line with general criteria outlined during the participatory process and consisted of a computer-generated replication of Hamars town square Norway Each participant would enter this town square as a virtual avatar with virtual arms and body The position of the arms was tracked by the hand-held controllers A large screen would appear in the virtual town square showing a video in which an instructor guided the exercises for the various sessions This was the same video as shown on the TV screen
Data collection at baseline Participant were assessed according to the Polysymptomatic Distress Scale PDS The Widespread Pain Index and Symptom Scale that together compose thePDS were completed by participants The PDS is composed of variables used in the 2010 American College of Rheumatology ACR fibromyalgia criteria which were later modified for use in clinical research and self-evaluation in epidemiological surveys 17-19 The PSD is thus both a diagnostic aid and a measure of fibromyalgia severity A diagnosis of fibromyalgia may be indicated by a PSD score of 12 or more in an epidemiological study1 The PDS has been translated and validated in Norwegian 20
Outcome measures HR was registered throughout the sessions using a HR-monitors worn at the wrist Garmin Forerunner 55 The mean HRs for the last three minutes of each session were calculated for each individual For the aerobic exercise sessions HR was also categorised into HR-zones according to the ACSM recommendations based on the participants predicted maximal HR 220 minus age 4 with the proportion of time spent in moderate-vigorous exercise intensity HR 65 of maximum heart rate or more being calculated and used for further analysis
Participants also completed questionnaires
Statistics We compared the mean HR values recorded within the last three minutes of the warm-up vs all other sessions as well between each aerobic exercise VR-A vs TV-A and mindfulness sessions VR-M vs TV-M using paired Students t-test
The time spent in each HR category was compared using the paired Wilcoxon signed rank test and time in the moderate-vigorous vs low ACSM zone in the VR-A vs TV-A sessions using McNemars test for dichotomised variables
Comparisons between the self-reported measurements collected after the aerobic exercise VR-A vs TV-A and mindfulness sessions VR-M vs TV-M were performed using the paired Wilcoxon signed rank test for each session for ordinal data and McNemars test for dichotomised variables
The study was conducted according to the Helsinki declaration and approved by the Local committee for medical and health research ethics at the Inland Norway University of Applied Sciences Ref 20616405
Study design The study was designed as a randomised controlled trial with a cross-over design
Intervntion Each participant underwent five exercise sessions in total Firstly all participants performed a six- minutes warm-up session following instructions projected on a TV screen Subsequently the participants performed two aerobic exercise sessions identical in content and duration five- minutes once following the instructions from VR VR-A and once following the identical program that was displayed on a TV screen TV-A The allocation of the first aerobic exercise session as VR-A or TV-A was randomly assigned for each individual After completing the first aerobic exercise session the participants were subsequently asked to complete the second session guided through the opposite mode of delivery After the exercise sessions the same randomised cross-over design was followed for two five- minute mindfulness sessions with the participants undergoing in a counter-balanced and random order a guided mindfulness program once delivered through VR VR-M and once displayed on a TV screen TV-M
Virtual environment and technology In the VR-A and VR-M the participants wore a stand-alone HMD Oculus Quest 2 with stock headstrap Meta Platforms Menlo Park California USA The virtual environment was developed by Fynd Reality AS Hamar Norway in line with general criteria outlined during the participatory process and consisted of a computer-generated replication of Hamars town square Norway Each participant would enter this town square as a virtual avatar with virtual arms and body The position of the arms was tracked by the hand-held controllers A large screen would appear in the virtual town square showing a video in which an instructor guided the exercises for the various sessions This was the same video as shown on the TV screen
Data collection at baseline Participant were assessed according to the Polysymptomatic Distress Scale PDS The Widespread Pain Index and Symptom Scale that together compose thePDS were completed by participants The PDS is composed of variables used in the 2010 American College of Rheumatology ACR fibromyalgia criteria which were later modified for use in clinical research and self-evaluation in epidemiological surveys 17-19 The PSD is thus both a diagnostic aid and a measure of fibromyalgia severity A diagnosis of fibromyalgia may be indicated by a PSD score of 12 or more in an epidemiological study1 The PDS has been translated and validated in Norwegian 20
Outcome measures HR was registered throughout the sessions using a HR-monitors worn at the wrist Garmin Forerunner 55 The mean HRs for the last three minutes of each session were calculated for each individual For the aerobic exercise sessions HR was also categorised into HR-zones according to the ACSM recommendations based on the participants predicted maximal HR 220 minus age 4 with the proportion of time spent in moderate-vigorous exercise intensity HR 65 of maximum heart rate or more being calculated and used for further analysis
Participants also completed questionnaires
Statistics We compared the mean HR values recorded within the last three minutes of the warm-up vs all other sessions as well between each aerobic exercise VR-A vs TV-A and mindfulness sessions VR-M vs TV-M using paired Students t-test
The time spent in each HR category was compared using the paired Wilcoxon signed rank test and time in the moderate-vigorous vs low ACSM zone in the VR-A vs TV-A sessions using McNemars test for dichotomised variables
Comparisons between the self-reported measurements collected after the aerobic exercise VR-A vs TV-A and mindfulness sessions VR-M vs TV-M were performed using the paired Wilcoxon signed rank test for each session for ordinal data and McNemars test for dichotomised variables
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None